Sweden · Delayed Price · Currency is SEK Medivir AB Earnings Call Transcripts
Fiscal Year 2025
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Strong pipeline progress with MIV-711 advancing into phase II for OI after new funding and FDA orphan drug status, Fostrox liver cancer study on track, and partnered VBX-1000 showing promising animal health results. Cash runway extends into 2028.
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A novel liver-targeted therapy for advanced liver cancer is advancing to a phase II trial, aiming to fill a major gap in second-line treatment. Early results show strong tumor response and extended progression times, with a $2.5–3 billion market opportunity.
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Announced a fully guaranteed rights issue to fund a phase II study of fostrox + Lenvima in second-line liver cancer, with rapid data generation targeted. Outlicensed Remetinostat to Biossil, securing milestone and royalty potential. Q3 financials showed improved operating loss and cash flow.
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Fostrox plus Lenvima continues to lead in second-line advanced HCC, supported by strong clinical data and new patent protection in Japan. Financials are stable with reduced costs and a SEK 38 million cash position, but future progress depends on securing additional funding.
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Final data from the fostrox + Lenvima study in liver cancer showed strong efficacy and safety, with patent protection extended to 2041. Preparations for the phase IIb study continue, pending additional financing, while the cash runway extends into Q4 2025.
Fiscal Year 2024
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Q4 2024 saw strong progress in fostrox development, including FDA IND approval for the phase II-B FOcuS-2 study and robust clinical data supporting further advancement. Financials were in line with expectations, with increased clinical costs and a cash runway into Q4 2025.
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Fostrox plus Lenvima showed strong efficacy in second-line liver cancer, with a median time to progression of nearly 11 months and favorable safety. The Eisai collaboration secures drug supply and $15–20 million in cost savings for the phase 2b study, while financing options remain open.
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Fostrox plus Lenvima showed a median time to progression of 10.8 months in second-line liver cancer, outperforming historical controls. Q2 financials were in line with expectations, with a cash runway into Q1 2025 and preparations for a phase IIb study progressing well.